HPLC法同时测定复方三维右旋泛酸钙糖浆中4种维生素的含量

Simultaneous determination of 4 major B-vitamins in Compound Trivitamin and Calcium Pantothenate Syrup by HPLC

目的建立高效液相色谱(HPLC)法同时测定复方三维右旋泛酸钙糖浆中维生素B_1、维生素B_2、维生素B_6和烟酰胺的含量。方法采用外标法进行测定,色谱柱为Thermo Betasil C_(18) Analytical(4.6 mm×250 mm,5μm),流动相为乙腈-5 mmol·L^(-1)十二烷基硫酸钠(含0.05%甲酸)水溶液梯度洗脱,流速1.0 mL·min^(-1),检测波长260nm,柱温30℃。分别测定10批复方三维右旋泛酸钙糖浆。结果维生素B_1、维生素B_2、维生素_B6、烟酰胺4种成分的线性范围分别为5.76~115.2μg·mL^(-1)(r=0.999 9)、1.16~23.20μg·mL^(-1)(r=0.999 9)、1.72~34.4μg·mL^(-1)(r=0.999 6)和5.76~115.2μg·mL^(-1)(r=0.999 9),平均加样回收率为96.2%~98.4%(RSD为2.14%~3.42%)。不同批次复方三维右旋泛酸钙糖浆中维生素B_1、维生素B_2、维生素B_6、烟酰胺含量范围分别为0.133 7~0.155 9、0.027 86~0.030 71、0.039 05~0.047 7、0.138 7~0.148 2 mg·g^(-1)。结论该方法为完善复方三维右旋泛酸钙糖浆的质量标准和加强质量控制提供了新的方法和依据。

Objective To establish an HPLC method for the simultaneous determination of 4 major B-vitamins including thiamine,riboflavin,pyridoxine and nicotinamide in Compound Trivitamin and Calcium Pantothenate Syrup.Methods The external standard method was established with a Betasil C18 Analytical（ 4.6 mm×250 mm,5 μm） column by a gradient elution using acetonitrile and 5 mmol·L-1 sodium dodecyl sulfate that include 0.05% formic acid in water at 30 ℃,the flow rate was 1.0 m L·min-1,and the detection wavelength was set at 260 nm.10 batches of samples were detected.Results The linear ranges of thiamine,riboflavin,pyridoxine and nicotinamide were 5. 76 115. 2 μg · mL-1（ r = 0.999 9）,1.16 23.20 μg·mL-1（ r= 0.999 9）,1.7234.4 μg·mL-1（ r= 0.999 6） and 5.76115.2 μg·mL-1（ r = 0.999 9） respectively.The average recoveries were 96.2% 98.4% with the RSDs ranging from 2.14% to 3.42%.The content ranges of thiamine,riboflavin,pyridoxine and nicotinamide in Compound Trivitamin and Calcium Pantothenate Syrup from 10 batches of samples were 0.133 7 0.155 9,0.027 86 0.030 71,0.039 05 0.047 7,0.138 7 0.148 2 mg·g-1.Conclusion The method provided a method and basis for improving the quality standard of Compound Trivitamin and Calcium Pantothenate Syrup.